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Study slams anti-depressant research

Report finds 'disturbing shortcomings' in earlier trials on drugs for kids

By ROD MICKLEBURGH

UPDATED AT 12:39 PM EDT Friday, Apr. 9, 2004

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A team of medical researchers has issued a strong call for doctors to reconsider prescribing widely used anti-depressant drugs to children, after finding "disturbing shortcomings" in a number of clinical trials on their effectiveness.

In a study published today in the British Medical Journal, the team of five Australian university researchers concludes that anti-depressant drugs cannot confidently be recommended as a treatment option for childhood depression.

Their powerful recommendation ads to the growing clamour against the routine prescription of drugs known as SSRIs (selective serotonin reuptake inhibitors) to troubled young patients.

Critics charge that SSRIs show little benefit over placebos in treating childhood depression, while increasing suicidal thoughts in some.

Yet, they are increasingly popular. Last year, more than 450,000 Canadians 19 years and under were treated by doctors for depression. Anti-depressant medication was prescribed to 75 per cent of them.

Some estimate that the number of annual SSRI prescriptions for young people has risen 58 per cent in Canada since 1998. At the same time, in the United States, the use of anti-depressant drugs by preschoolers nearly doubled from 1998 to 2002.

The most well-known SSRIs include Prozac, Zoloft, Luvox, Paxil, Effexor, Celexa and Remeron.

Britain has effectively halted prescription of all SSRIs except Prozac to those under 18, while Health Canada issued a warning earlier this year that advised anyone under 18 taking an SSRI anti-depressant to consult their doctor.

Dr. Jane Garland, head of the Mood and Anxiety Disorders Clinic at the Children's Hospital in Vancouver, said she agreed "absolutely" with the BMJ study.

She said it echoes her own observations in a recent edition of the Canadian Medical Association Journal.

"There is a possibility of small benefits for some patients, but the majority of the time, SSRIs demonstrate no benefit over placebos. I think we should be alarmed at such an uncritical acceptance of SSRIs by supposedly scientific practitioners," she said. "This is another nail in the coffin for SSRIs . . . but even as the evidence mounts, it doesn't seem to change prescription practices."

The researchers examined six previously published, randomized controlled trials involving the use of SSRIs by depressed children. They noted that the authors of three of the trials were paid for their work by pharmaceutical companies.

Benefits were exaggerated and harms were downplayed, according to the BMJ study, which also noted that placebos had virtually the same positive impact on young patients as SSRIs.

In one trial looked at by the researchers, 9 per cent of those being treated with the SSRI drug Zoloft withdrew because of adverse affects, compared with a 3-per-cent withdrawal by those taking a placebo. Despite these results, the BMJ report stated: "The authors [of the Zoloft study] concluded that [Zoloft] is an effective, safe and well tolerated short-term treatment for children and adolescents."

These, and other suspect trials, "raise the question of whether the journals that published the research reviewed the studies with a sufficient degree of scrutiny, given the importance of the subject," the Australian researchers said.

"We are concerned that biased reporting and overconfident recommendations in treatment guidelines may mislead doctors, patients and families.

"It is vital that authors, reviewers and editors ensure that published interpretations of data are more reasonable and balanced than is the case in the industry-dominated literature on childhood anti-depressants."

Despite accumulating evidence against the efficacy of SSRIs, however, Dr. Garland said there is still a place for them in treating childhood depression. She said they have been proven effective in treating anxiety disorders, and doctors continue to prescribe them for depression "because they work."

Dr. Garland explained that about 80 per cent of patients improve after taking SSRIs, even if 60 per cent taking a placebo also improve and some patients would have become better without medication.

But Dr. Garland added physicians must be more aware of possible adverse side effects to young patients and should understand that the clinical benefit isn't high.


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